Research Scientist I - E&L

About the role

This role involves planning laboratory work in mass spectroscopy and E&L, including independent execution of laboratory studies at in-house or external labs. The candidate will likely act as study director for multiple studies at any given time and is expected to be capable of performing wet chemistry and mass spectroscopy (GC, LC, and other appropriate methods) hands-on as needed.

Responsibilities

• Play a key role in the materials, chemical characterization and E&L team and bring hands-on and significant technical leadership experience in mass spectroscopy, extractables and leachables for medical device and drug products.
• Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support extractables & leachables projects and change control activities.
• Collaborate with a multidisciplinary team of subject matter experts (e.g., Materials, Biocompatibility, and Toxicology) to develop E&L strategies that align to regulatory requirements for medical devices and drug products.
• Perform E&L change control impact assessments and work with cross-functional team members (design owners, materials, preclinical, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to E&L.
• Utilize expertise in E&L to perform gap assessments for medical device requirements and support change control activities across the Renal and Acute Care businesses within Vantive.
• Work closely with regulatory, quality, preclinical and product design owning leaders to shape, define and execute product enhancement strategies (for both on-market and new product development) from the perspective of E&L.
• Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization product development, design, and safety.
• Author required reports (internal documentation and regulatory submissions) following pertinent internal and external guidelines and quality procedures that ensure safety and compliance of drugs or devices that Vantive makes.
• Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs.
• Stay abreast of emerging sciences and technologies that influence chemical characterization including E&L for medical devices and drugs through active participation in relevant external forums / societies.

Requirements

• Bachelor’s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum of 10+ years of relevant experience, or MS with a minimum 7+ years of relevant experience or PhD with a minimum 3+ years of relevant experience.
• Hands-on Experience and demonstrated expertise in E&L testing (from wet chemistry sample preparation to Mass spectroscopy using GC and LC methods).
• Study director experience in leading E&L studies, working in cross-functional teams and on-time, on-budget-project execution.
• Demonstrated experience in applying risk management methods and tools as part of R&D (preferred).
• Understanding regulatory expectations and writing cohesive and concise E&L reports for submission to the health authorities (preferred).
• Performing change control in a GMP environment. (preferred)
• Being an independent problem solver, who can use a methodical approach to develop solutions, perform root cause analysis, make and implement recommendations. (preferred)